Precision Oncology – The Quest for Evidence.

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Precision Oncology – The Quest for Evidence

The molecular characterization of patient tumors provides a rational and highly promising approach for guiding oncologists in treatment decision-making. Notwithstanding, genomic medicine still remains in its infancy, with innovators and early adopters continuing to carry a significant portion of the clinical and financial risk. Numerous innovative precision oncology trials have emerged globally to address the associated need for evidence of clinical utility. These studies seek to capitalize on the power of predictive biomarkers and/or treatment decision support analytics, to expeditiously and cost-effectively demonstrate the positive impact of these technologies on drug resistance/response, patient survival, and/or quality of life. Here, we discuss the molecular foundations of these approaches and highlight the diversity of innovative trial strategies that are capitalizing on this emergent knowledge. We conclude that, as increasing volumes of clinico-molecular outcomes data become available, in future, we will begin to transition away from expert systems for treatment decision support (TDS), towards the power of AI-assisted TDS-an evolution that may truly revolutionize the nature and success of cancer patient care.

 

Cancer Drug Resistance. (J Pers Med. 2019 Sep 5;9(3). Soldatos, Kaduthanam, Jackson. doi: 10.3390/jpm9030043.

Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

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Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

 

Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

 

  • Molecular Health Guide (MH Guide) gains ground in important U.S. market
  • MH Guide easily translates complex genetic data to support intelligent personalized medical decisions

Heidelberg, Germany – May 31, 2019 – Molecular Health (MH), a leading company in the field of data science for precision medicine, today announced that the Company has signed up the HudsonAlpha Institute for Biotechnology (HudsonAlpha) as a new client for MH Guide. HudsonAlpha is a nonprofit institute dedicated to developing and applying scientific advances to health, agriculture, learning, and commercialization.

 

MH Guide enables smarter patient care decisions based on deeper and broader biomedical information: Molecular pathologists and human geneticists can interpret genetic data derived from different technologies, such as next-generation sequencing, and create clinical reports that include drug information and variant classifications in minutes – easily, confidently, and accurately. HudsonAlpha plans to use MH Guide to elucidate detailed information on mutations found in patient tumor samples.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said: ”Molecular Health is increasing its footprint in the U.S. as we sign on important new clients for our products. We are delighted to welcome HudsonAlpha as a customer and look forward to contributing through MH Guide to the important work they are doing to advance science and healthcare.”

 

About MH Guide
MH Guide, the gold standard in genomic data processing and analysis, is a rich bioinformatics platform, allowing medical professionals to analyze variants in the context of a patient’s cancer disease or predisposition to support identification of the potentially most effective treatments or disease predispositions. Molecular Health integrates private and publicly available databases, peer-reviewed scientific literature, and genome studies to extract salient information categorized by gene variant, disease, indication, cancer pharmacogenetics, and other relevant clinical classifiers. The stringent quality process Molecular Health follows to annotate and create its medical content is what sets MH Guide apart. Clients retain ownership of all data at all stages of the analysis, including the analysis results, which can be provided in a variety of digital formats, and have access to all source evidence for the annotations provided by the system. MH Guide is the first software product approved as an IVD medical device by the EU and is currently eligible for reimbursement in the EU.

Molecular Health appoints Christian Meisel, MD, PhD, as Chief Medical Officer

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Molecular Health appoints Christian Meisel, MD, PhD, as Chief Medical Officer

Heidelberg, Germany – Tuesday, May 7, 2019–Molecular Health, a leading company in the field of data science for precision medicine and specializing in the development of products and services leveraging its proprietary biomedicine technology platform Dataome, today announced the appointment ofDr. Christian Meisel as corporate Chief Medical Officer (CMO).

 

Dr. Meiselcomes to Molecular Health with over 25years of experience in the healthcare sector–including clinical practiceand research &development across academia and the biopharmaceutical industry–andmore than 10 years in senior pharma leadership roles. As anMDandPhD with additional qualifications in computer science and extensive experience in precision medicine, Dr. Meisel will be responsible for all clinical aspectsof Molecular Health’sportfolioand development. As a member of the company’s leadership,he will also provide strategicdirection and leadership in the development of Molecular Health.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said:”Weare very pleasedto have Dr. Meisel join as our Chief Medical Officer. He not only is anexperiencedphysician but, next to his background in computer science, also brings an extensivetrack record and expertise in precision medicineacross the biopharmaceutical and diagnostics industry. With his broadexperience in molecular diagnostics and drug development,he is a perfect addition to our development and commercial teams and willstrategically enhanceand further sharpen thefocus of our offerings to pharma, physicians, providers, payersand the financial industry. The CMO position is key for our growth strategy, and we are happy to havefound Christianfor this important role at Molecular Health.”

 

Dr. Meisel adds: “I am very much looking forwardto joiningMolecular Health –a company at the forefront of the digital transformation of medicine and R&D –as a member of the executive team. I will bring my first-hand experience and deep knowledge of the demandsof patients and healthcare providers to further improveMolecular Health’s innovative solutions to impact patient care,therapeutic and diagnostic product development,and meet the growing needs of the medical community in the digitalization of healthcare.”

 

Dr. Christian Meisel joins Molecular Health from Roche where heserved for more than 14 years in numerous senior leadership roles, including Global Head Personalized Healthcare Platform, acting Global Head Translational Medicine Oncology, and Global Head Biomarkers and Translational R&D Innovation. Dr. Meisel is board-certified in Internal Medicine and in Clinical Pharmacology, holds an MD from the Technical University of Munich, and a PhD from Charité Berlin, where he also served as associate professor and leader of a bioinformatics research group.

 

About Molecular Health

Molecular Health is a data science-focused artificial intelligencecomputing company enabling and improving decision making in precision medicine for healthcare organizations.The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets andcombining them with novel artificial intelligence and machine learning (AI/ML) technologies.For more than a decade, the company has been developingDataome, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes.Dataome –stand alone or in combination with customer data –enables the unlocking of actionable intelligence at the molecular level toa)improve diagnosis and therapy decisions by physicians and patients;b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations;andc) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation.For more information,visit www.molecularhealth.com.

 

Molecular Health GmbH
Thomas König
Head of Marketing
thomas.koenig@molecularhealth.com

 

Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
molecularhealth@mc-services.eu
+49-89-210 2280

Molecular Health holds industry symposium at DGP Annual Meeting in Frankfurt

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Molecular Health holds industry symposium at DGP Annual Meeting in Frankfurt

Molecular Health is sponsor and exhibitor at the 103rd Annual Meeting of the German Society of Pathology in Frankfurt.

It holds a lunch symposium on „Scaling the analysis and interpretation of NGS data with the medical device MH Guide in a clinical setting“ (Saturday, June 15, 12:15-1:45 pm). Prof. M. Kanai (Kyoto University Hospital) and Prof. M. Hummel (Charité Institute of Pathology) share their experiences with MH Guide in daily clinical routine.

http://www.professionalabstracts.com/pathologie2019/Iplanner/#/grid

Molecular Health ’s MH Guide shortlisted for the German Digital Health Award 2019

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Molecular Health ’s MH Guide shortlisted for the German Digital Health Award 2019

• Molecular Health Guide (MH Guide) shortlisted forthe German Digital Health Award 2019
• Novartis and Sandoz/Hexal nominate seven out of 119 submissions
• MH Guide enables evidence-based cancer therapy decisions for physicians, patients and health insurers

 

Heidelberg, Germany–Monday, February 18, 2019–Molecular Health (MH), a leading company in the field of data science for precision medicine and specializing in the development of products and
services leveraging its proprietary biomedicine technology platform Dataome, has been shortlisted for the German Digital Health Award 2019. As Novartis Pharma and Sandoz Germany/Hexal announced earlier, MH Guide is one of only seven entriesselected from a total of 119 submissions. The German Digital Health Award is given to sustainable digital solutions to improve healthcare in Germany. The
2nd annual awards ceremony will take place in Berlin on March 20, 2019.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said: ”We are delighted to be shortlisted for the German Digital Health Award 2019 and by the recognition this means for our work. At Molecular Health, we are constantly seeking smart solutions to address the challenges in cancer healthcare. Nine renowned experts have been appointed to the jury by Novartis, and their
nomination reinforces that we are following a future-oriented and sound path.”

 

With MH Guide, physicians in their everyday cancer practice can make an evidence-based therapy decision that takes into account the individual patient’s tumor characteristics. Utilizing MH’s
proprietary technology platform Dataome, MH Guide generates a summary of potentially effective medications, potentially ineffective medications, and medications that may pose a higher risk of adverse reactions or be predictive for an increased risk of cancer progression. MH Guide is the first software product approved as an IVD medical device by the EU and is currently eligible for reimbursement.

 

About Molecular Health
Molecular Health is a data science-focused artificial intelligence computing company enabling and improving decision making in precision medicine for healthcare organizations.The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets and combining them with novel artificial intelligence and machine learning (AI/ML) technologies. For more than a decade, the company has been developing Dataome, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes.Dataome – stand alone or in combination with customer data – enables the unlocking of actionable intelligence at the molecular level to a) improve diagnosis and therapy decisions by physicians and patients; b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations; and c) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation.
For more information,visit www.molecularhealth.com.

 

Related News:
https://www.novartis.de/news/media-releases/shortlist-mit-sieben-projekten-fuer-den-digitalen-gesundheitspreis-von-novartis
https://www.novartis.de/aktuelles/digitaler-gesundheitspreis

 

Molecular Health GmbH
Thomas König
Head of Marketing
thomas.koenig@molecularhealth.com

 

Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
molecularhealth@mc-services.eu
+49-89-210 2280

Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

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Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

Peter Schotland, Rebecca Racz, David Jackson, Robert Levin, David G. Strauss and Keith Burkhart

Molecular Health Licenses its Proprietary Predictive Analytics to DATEN CAPITAL

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Molecular Health Licenses its Proprietary Predictive Analytics to DATEN CAPITAL

• Molecular Health Predict enables highly accurate estimates of clinical trial success probabilities 
• Exclusive license for the financial industry granted to DATEN CAPITAL  
• Molecular Health to receive an annual license fee and success-based payments  

 

Heidelberg, Germany and Boston, MA — Monday, January 7, 2019 — Molecular Health, a leading company in the field of data science for precision medicine and specializing in the development of products and services leveraging its proprietary biomedicine technology platform Dataome®, is pleased to announce that it has granted an exclusive license for Molecular Health Predict (MH Predict) to DATEN CAPITAL LLP (DATEN), for its use in the financial industry. MH Predict was developed by Molecular Health to calculate the likelihood of success of drug clinical trials, and DATEN is a private limited liability partnership founded to commercialize data-science, AI-driven approaches to investing. Molecular Health will receive an annual license fee as well as success-based payments from DATEN. Friedrich von Bohlen, PhD, Cofounder & CEO of Molecular Health GmbH, said: “We are very excited to announce this exclusive license for the financial industry with DATEN CAPITAL. Understanding and effectively predicting the likelihood of success of clinical trials is critical to achieving better efficiencies and savings in drug R&D – which today still represents billions of dollars of annual losses due to trial attrition for both pharmaceutical companies and investors. We believe that MH Predict will drive a true paradigm shift in drug development, resource and investment allocations and ultimately patient outcomes. We look forward to launching this product also to the pharmaceutical industry in early 2019.” “I came to know Friedrich von Bohlen and Molecular Health during my time in investment banking at Goldman Sachs. After learning more about the company, and assessing its technology, I became increasingly convinced of the potential for Molecular Health to transform the drug development industry. Our mission when founding DATEN CAPITAL was to build a data-science, AI-driven approach to allocating capital. This is why we are particularly excited to have obtained an exclusive license to apply MH Predict to the financial markets. Our aim, and our belief, is that we will help enable the biopharmaceutical industry to deliver new drugs to the market in a much better, faster and cheaper way,” said Amit R. Karna, CFA, Managing Partner at DATEN CAPITAL LLP.  

 

About MH Predict  

MH Predict is an artificial intelligence (AI) based product that predicts the likelihood of success of a clinical trial to achieve its endpoints. Models are designed and validated based on a range of public and proprietary data sources, including Dataome®, a proprietary database custom built by Molecular Health over 10 years and with over €150m of invested capital.  

 

About Molecular Health  

Molecular Health is a data science-focused artificial intelligence computing company enabling and improving decision making in precision medicine for healthcare organizations. The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets and combining them with novel artificial intelligence and machine learning (AI/ML) technologies. For more than a decade, the company has been developing Dataome®, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes. Dataome® – stand alone or in combination with customer data – enables the unlocking of actionable intelligence at the molecular level to a) improve diagnosis and therapy decisions by physicians and patients; b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations; and c) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation. For more information, visit www.molecularhealth.com. 

 

About DATEN CAPITAL

DATEN CAPITAL LLP (DATEN) is a private limited liability partnership incorporated in England and Wales (registered no: OC424550). The firm was founded in 2018 with a mission to apply data-science, AI-driven solutions to the financial markets. DATEN plans to initially focus on the biotech sector, primarily in the US and Europe. The Managing Partner for DATEN is Amit R. Karna, CFA, a former investment banker who spent ten years in the healthcare team at Goldman, Sachs & Co., based initially in New York before transferring to London. DATEN CAPITAL LLP is backed by leading investors and individuals in the healthcare and technology sectors. For more information, visit www.datencapital.com

 

Molecular Health Predict (MH Predict)
Blanca Baez
Global Head of Pharma & Biotech
 
Molecular Health GmbH
Thomas König
Head of Marketing
 
Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
+49 – 89 – 210 2280
 

MH Guide for labs: Augment your annotations quickly

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MH Guide for labs: Augment your annotations quickly

Benefit from our software-aided interpretations for personalized cancer treatment

• Latest and comprehensive clinical evidence gathered from top publications/databases
• Oncologist/pathologist reviewed annotations that include treatment options
• Seamless integration into existing lab workflow
• Intuitive UI/UX
• Cloud-based portal for rapid and secure processing

Target‐Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

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Target‐Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

Abstract

Clinical trials can fail to detect rare adverse events (AEs). We assessed the ability of pharmacological target adverse‐event (TAE) profiles to predict AEs on US Food and Drug Administration (FDA) drug labels at least 4 years after approval. TAE profiles were generated by aggregating AEs from the FDA adverse event reporting system (FAERS) reports and the FDA drug labels for drugs that hit a common target. A genetic algorithm (GA) was used to choose the adverse event (AE) case count (N), disproportionality score in FAERS (proportional reporting ratio (PRR)), and percent of comparator drug labels with an AE to maximize F‐measure. With FAERS data alone, precision, recall, and specificity were 0.57, 0.78, and 0.61, respectively. After including FDA drug label data, precision, recall, and specificity improved to 0.67, 0.81, and 0.71, respectively. Eighteen of 23 (78%) post-market label changes were identified correctly. TAE analysis shows promise as a method to predict AEs at the time of drug approval.

Association Between Serotonin Syndrome and Second-Generation Antipsychotics via Pharmacological Target-Adverse Event Analysis

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Association Between Serotonin Syndrome and Second-Generation Antipsychotics via Pharmacological Target-Adverse Event Analysis

Racz, Soldatos, Jackson, Burkhart. Clin Transl Sci (2018) 00, 1–8; doi:10.1111/cts.12543